FDA Documents Show It Ignored GMO Safety Warnings from Its Own Scientists.

• Author: Druker, Steven

In May 1998, a coalition of public interest groups, scientists, and religious leaders filed a landmark lawsuit against the US Food and Drug Administration to obtain mandatory safety testing and labeling of all genetically engineered foods (Alliance for Bio-Integrity, et. al. v. Shalala). Nine eminent life scientists joined the coalition in order to emphasize the degree to which they think FDA policy is scientifically unsound and morally irresponsible. Now, the FDA's own files confirm how well-founded are their concerns. The FDA was required to deliver copies of these files--totaling over 44,000 pages--to the plaintiffs' attorneys.

False Claims and a Policy at Odds with the Law

The FDA's records reveal it declared genetically engineered foods to be safe in the face of disagreement from its own experts--all the while claiming a broad scientific consensus supported its stance. Internal reports and memoranda disclose: (1) agency scientists repeatedly cautioned that foods produced through recombinant DNA technology entail different risks than do their conventionally produced counterparts, and (2) that this input was consistently disregarded by the bureaucrats who crafted the agency's current policy, which treats bioengineered foods the same as natural ones.

Besides contradicting the FDA's claim that its policy is science-based, this evidence shows the agency violated the US Food, Drug and Cosmetic Act in allowing genetically engineered foods to be marketed without testing on the premise that they are generally recognized as safe by qualified experts.

FDA Scientists Protest Attempt to Equate Genetic Engineering with Conventional Breeding

The FDA admits it is operating under a directive "to foster" the US biotech industry and this directive advocates the premise that bioengineered foods are essentially the same as others. However, the agency's attempts to bend its policy to conform with this premise met strong resistance from its own scientists, who repeatedly warned that genetic engineering differs from conventional practices and entails a unique set of risks. Numerous agency experts protested that drafts of the Statement of Policy were ignoring the recognized potential for bioengineering to produce unexpected toxins and allergens in a different manner and to a different degree than do conventional methods.

According to Dr. Louis Priybl of the FDA Microbiology Group, "There is a profound difference between the types of unexpected effects from...